Apparatus and method for fixation of osteoporotic bone

ABSTRACT

A Novel surgical apparatus and method of use in osteoplasty and other methods of injecting materials into a subject for medical purposes. The present invention particularly relates to the surgical treatment of traumatic, pathogenic, or osteoporotic bone conditions of the human and other animal body systems and more particularly, to a novel apparatus and method for injection of a material into a lesion of a vertebral body or other bony structure.

[0001] This application is a Continuation-In-Part of U.S. patentapplication Ser. No. 09/525,008, filed Mar. 14, 2000, which claimedpriority to U.S. Provisional Patent Application No. 60,124,661 filedMar. 16, 1999, U.S. Provisional Patent Application No. 60/133,276 filedMay 10, 1999, and U.S. Provisional Patent Application No. 60/167,017filed Nov. 23, 1999. U.S. patent application Ser. No. 09/525,008 wasalso filed as PCT Application No. PCT/US00/06643 on Mar. 15, 2000. Thepresent Continuation-In-Part application also claims priority to U.S.Provisional Patent Application No. 60/242,707 filed Oct. 25, 2000 andU.S. Provisional Application No. 60/270,867 filed Feb. 26, 2001.

[0002] This invention relates to a novel surgical apparatus for use inosteoplasty and-other methods of injecting materials into a subject formedical purposes. Particularly, the present invention relates to thesurgical treatment of traumatic, pathogenic, or osteoporotic boneconditions of the human and other animal body systems and moreparticularly, to a novel apparatus and method for injection of amaterial into a lesion of a vertebral body or other bony structure.

BACKGROUND

[0003] Lesions within the bone can result from osteoporosis, tumor, orother pathogenic causes. Most common among the elderly population is thedegenerative effect of osteoporosis, particularly the female elderly.Osteoporosis is mediated at least in part by genetic defects and a fallin circulating estrogen levels. Although calcium replacement therapy canhave some beneficial effects, the larger doses of calcium involved haveother less helpful consequences and accordingly, the prognosis for thosewith bone demineralization is not particularly good. Of great concern isthe fact that every year in the United States there occurs approximately1.2 million bone failures due to osteoporosis. Vertebral compressionfailures are a major orthopedic health concern of the elderly due to thelong term debilitating nature of the injury.

[0004] Historically, osteoporotic vertebral body compression failureshave been treated with bed rest, analgesics, and intravenous hydrationduring the first week after onset of the problem. These steps arefollowed by the prescription of a soft or firm spinal corset, dependingupon the physician's preference. In most cases the corset is not wornbecause the patient suffers much discomfort and oftentimes greaterdiscomfort than that due to the failure of the vertebral body. In anycase, this conventional approach required extensive hospitalization andbed rest, which often results in very limited success, chronic pain, andfurther osteoporosis with worsening conditions of the vertebral body.The costs associated with such extended hospitalization and the negativeeffect on the general health of the patient from such prolongedinactivity should be avoided if possible.

[0005] Traditional surgical techniques employed to alleviate vertebralcompression failures can involve major invasive surgical techniques withall of the possible negative consequences. Such techniques havetypically required prolonged patient recuperation and unfortunately havemet with limited success in alleviating pain and returning the patientto a normal life style.

[0006] More recently efforts have been made to develop surgicaltechniques for repair of vertebral compression failures of osteoporoticbone by using conventional instruments in a transpedicular approach topenetrate the vertebral body, including a standard syringe, and theninject a flowable synthetic bone material or bone cement directly intothe vertebral body through the syringe. This technique of vertebroplastyrequires that the physician take the utmost care to avoid damage to thespinal cord when drilling through the narrow dimensions of the pedicleof the vertebrae. To avoid potentially catastrophic results physicianspracticing conventional vertebroplasty require the use of CAT scanning,biplane fluoroscopy, magnetic resonance imaging, or other imagingdevices to ensure the proper alignment of the instruments, which borethrough and are passed through the narrow pedicle. The availability ofCAT scanning or sophisticated biplane fluoroscopy in surgical proceduresis limited due to the additional cost associated with equipping surgicalsuites with the necessary equipment. Further, to protect againstaccidental damage to the spinal cord during the conventionaltranspedicular approach to the vertebral body, the patient is typicallyplaced in a restraining device and stereotaxic procedures are used toguide the physician's drill and cannulae through the pedicle. Due to theextraordinary care and precision required in conventionalvertebroplasty, the time needed to complete the surgery and the costassociated with the procedure can be extensive. Further, generalanesthetic is not recommended due to the close proximity of thephysician's instruments to the spinal cord and the associated need tocommunicate with the patient. This requirement, however, also causesconcern of movement of the patient during the surgery; movement whichcould have serious consequences should the spinal cord be damaged as aresult. Scholten et al. in U.S. Pat. Nos. 4,969,888 and 5,108,404teaches the conventional surgical technique of vertebroplasty with theadditional step of employing a balloon as an expansion device within thebody of the vertebrae to compact the osteoporotic cancellous bone awayfrom the center and against the walls of the vertebral body. Thisadditional step to conventional vertebroplasty, taught by Scholten etal., is intended to provide additional space within the vertebral bodyto accept the flowable bone cement through the needle (syringe). Whilethe conventional vertebroplasty technique using conventional surgicalapparatus has the distinct disadvantage of drilling through the pediclewith the potential risk of damage to the spinal column, this additionalballoon expander employed in the process of Scholten et al., provides anadditional disadvantage by compressing the naturally present internalmatrix of the osteoporotic vertebra against the wall of the vertebralbody. Absent this natural matrix, the injection of bone cement into thecavity created by the compressing step results in the formation of anunstructured bolus of bone cement in the center of the vertebral body.Because of the compression of cancellous bone, which as a result linesthe walls of the vertebra, the bone cement which is infused into thevertebral body does not make a strong, direct, bonding contact with thevertebral wall, thus resulting in a potentially weaker post-surgeryvertebral body.

[0007] There is, therefore, a great need for a surgical technique andassociated instrumentation by which osteoporotic bone can be safely,expeditiously and efficiently treated. There is a particular need for avertebroplasty procedure and associated instrumentation which provide asafer, faster procedure that ultimately results in a repair to theosteoporotic vertebral body wherein the injected material does notdisturb the natural matrix of the cancellous bone, which along withdirect contact to the vertebral wall provides a strong, compositematrix. The present invention provides an apparatus and a method ofpercutaneous bone failure fixation, which satisfies these needs.

SUMMARY OF THE INVENTION

[0008] The process and apparatus of the present invention can begenerally used to perform osteoplasty, that is the introduction of anyinjectable material into any of the bones or tissues of the body. Thepresent invention is particularly suitable for injecting materials intobones which have or are susceptible to compression failure due tolesions within cancellous bone. More particularly, this inventionrelates to a method and apparatus, involving the injection of materialsfor the fixation of lesions or failures of bones, particularly as aresult of osteoporosis, tumor, other pathogenic conditions or trauma.The invention is especially suitable for use in the vertebroplastyprocedures, such as, the fixation or prevention of vertebral bodycompression failures, although the instrumentation and methods of thepresent invention can be used for a wide variety of osteoplastyprocedures, such as, failures or lesions in bones throughout the body.

[0009] An object of the present invention is to provide an apparatus,which is useful for the surgical procedure of safely introducing amaterial into a lesion or space within or around a bone or tissue.

[0010] Another object of the present invention is to provide a surgicalmethod for safely introducing an injectable material into a lesion orspace within or around a bone or tissue.

[0011] More particularly, it is an object of the present invention toprovide an apparatus, which is sized and configured to safely contact orbreach the cortical bone and establish an introducing channel throughthe apparatus and through the cortical bone into the cancellous bonethrough which a material can be introduced. The material introduced intothe interior of the bone can be any biocompatible or therapeuticmaterials, such as, for example, antibiotics, whole cellular implants,natural products of cells, recombinant nucleic products, proteinproducts of recombinant cells, allograft or autograft bone, bone cementproducts as are well known in the art (such as polymethylmethacrylateand the like), or any other flowable material useful for therapeutic,prosthetic, or bone strengthening purposes.

[0012] Another object of the present invention to provide an apparatus,which is sized and configured to be used by a physician to safelyintroduce a material into the cancellous bone of a vertebral body. Inthe surgical procedure of the present invention the apparatus canintroduced by direct vision, open or percutaneously, laproscopically,thorascopically, or by open surgical procedures. The apparatus can beintroduced into the vertebral body by a variety of approaches, toinclude, for example, postero-lateral and lateral and/or bilateralpercutaneous approaches and a transpedicular approach. Such introductionof the apparatus can be accomplished with or without the conventionalrequirement for CAT scanning or sophisticated biplane fluoroscopy andfurther can be performed safely using general or local anesthetic.Introduction of the apparatus can be facilitated by use of indiciadisposed on the guide wire, the cannulae or both, which are part of theapparatus. The indicia can be radioopaque or radiotranslucent. Noirrigation, evacuation, or use of cancellous bone expanders is requiredfor the successful use of the apparatus to introduce the material intothe interior of the vertebral body.

[0013] Additionally, an object of the present invention is to provide amodular pedicle finder, which facilitates the placement of an instrumentfor penetrating the pedicle of a vertebra.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The invention will now be described, by way of illustration only,with reference to the accompanying drawings.

[0015]FIG. 1 is an isometric view of the components of the oneembodiment of the apparatus of the present invention.

[0016]FIG. 2 is an isometric view of the assembled Guide wire andAligning Cannulae of the present invention.

[0017]FIG. 3 is an isometric view of the assembled Delivery cannulae andPlunger of the present invention.

[0018]FIG. 4 depicts the present invention equipped with an optionalsyringe system.

[0019]FIG. 5 is a depiction of a guide wire that can be used in thepresent invention having a Luer lock for providing a fluid tightattachment to an infusion device, syringe or handle.

[0020]FIG. 6 is a depiction of a delivery cannulae that can be used inthe present invention, which is configured to be capable of receivingthe guide wire shown in FIG. 5.

[0021]FIG. 7 is a depiction of the assembled guide wire and deliverycannulae shown in FIGS. 5 and 6.

[0022]FIG. 8 is a depiction of a handle configured to be capable ofremovable attachment to the Luer lock of the guide wire shown in FIG. 5or the cannulae shown in FIG. 6.

[0023]FIGS. 9A, 9B and 9C are detail views of the handle shown in FIG.8.

[0024]FIG. 9D is a depiction of an embodiment of the handle shown inFIG. 8 which is configured with a removable proximal end for purposes ofexposing the proximal end of the guide wire for ease in movement,insertion, and extraction from the delivery cannulae. FIGS. 9E-9F showsexamples of some of the alternative end attachments, which can beemployed with the handle shown in FIG. 9D. FIGS. 9G-9H depict acannulated T-handle which can be used with the present invention. FIG.9I is a partial sectional view of an alternative embodiment of thepresent invention employing a handle having a removable proximal end,which acts an extended impact surface.

[0025] FIGS. 10A-10B are cross-sectional side (10A) and end (10B) viewsof the plunger shown in FIG. 10C, which can be used with the apparatusof the present invention. FIG. 10C is a depiction of the plungerassembly, which includes the handle shown in FIGS. 10A-10B. FIGS.10D-10J are various views of an alternative embodiment of a plunger thatcan be used with an embodiment of the present invention employing athreaded plunger and cannulae. FIG. 10K shows a mixing tip option whichcan be employed with the present invention.

[0026]FIG. 11A is a depiction of a hand operated plunger actuator whichcan be used with the apparatus of the present invention. FIG. 11B is adepiction of a type of syringe which can be used to contain a materialfor use in the method of the present invention, the syringe being anexample of the type syringe which can be used with the hand operatedplunger actuator shown in FIG. 11A. Unlike other plunger actuators, thisplunger actuator of the present invention allows for controlledinjection down to 1 cc of material per squeeze by the operator. FIGS.11C-11E are depictions of an alternative multilumen-type cannulae whichcan be used to contain more than one material for simultaneous orsequential injection in the method of the present invention.

[0027]FIG. 12A is a depiction of an application of the method of thepresent invention, which employs a flexible cannulae for delivery of amaterial into the bone material of a joint, such as, for example intothe acetabulum.

[0028]FIG. 12B is an enlarged cross-sectional depiction of the flexiblecannulae shown in FIG. 12A showing an example of a mechanism which canbe employed to steer the flexible cannulae. The plunger technologydepicted in FIG. 10 maintains a flexible shaft for delivery through theflexible lumen of the flexible cannulae.

[0029] FIGS. 13A-13B show a specialized impact forceps, which can beused with the device of the present invention for purpose offacilitating the entry of the device into the bone.

[0030]FIG. 14 and FIG. 15 are depictions of a conventional prior artmethod of vertebroplasty. FIG. 14. shows a transpedicular approach tothe vertebral body. FIG. 15 shows the deep penetration of the vertebralbody using a transpedicular approach.

[0031]FIG. 16 is a depiction of the apparatus of the present inventionpositioned relative to a sectional view of a vertebral body duringoperation of the method of the preferred embodiment of the presentinvention.

[0032]FIG. 17 is a depiction of a first alternative embodiment of themethod of the present invention showing a bilateral approach to thevertebra. Such a bilateral approach would preferably be done in order offirst one side and then the other, although the figure depicts bothsteps simultaneously.

[0033]FIG. 18 is a depiction of a second alternative embodiment of themethod of the present invention in which the cancellous bone ispenetrated with minimal disruption of the cancellous bone to permit moreextensive infusion of the injectable material.

[0034]FIG. 19 is a depiction of an exploded view of an adjustable handlemember for use with the present invention.

[0035]FIG. 20 is a small stature luerlock guide wire for use with thepresent invention.

[0036]FIGS. 21A, 21B and 21C are depictions of a loading syringeassembly for use with the present invention.

[0037]FIG. 22 is a depiction of a hand operated syringe gun shown inassembly with a delivery syringe tube, which can be used with thepresent invention.

DETAILED DESCRIPTION

[0038] The apparatus and method of the present invention can be adaptedfor use in the introduction of any material into any bone that containsa lesion or sufficient porosity to accept the materials. The employmentof the apparatus and surgical procedure of the present invention invertebroplasty; particularly to treat vertebral compression failureswhich result from osteoporotic conditions is herein described below asillustrative of the present invention.

[0039] The following description of the device of the present inventionrelates to FIGS. 1-3. The apparatus of the present invention is anintraosseous injection device generally shown at 1. One object of thepresent invention is to use the injection device I in a surgicalprocedure for the safe, effective introduction of materials into alesion within a bone, whereby the procedure includes the introduction ofa first guide wire 2 having a tapered end 4 for effectively breachingthe dense compact bone, for example, the cortical bone of the vertebra.An aligning cannulae 6 is configured and sized to easily pass over thefirst guide wire 2 and when passed down the shaft of the guide wire 2serves as a soft tissue protective sleeve from the point of entry of theapparatus into the body to the contact point at the exterior surface ofthe bone being treated. The aligning cannulae 6 has a blunt first end 8which has a textured surface to facilitate handling and a tapered secondend 10 which during operation of the instrument is brought into contactwith the bone being treated.

[0040] A delivery cannulae 12, which is sized and configured to easilypass over the aligning cannulae 6 is inserted over the aligning cannulae6 for purpose of providing a material conduit 14 through which theinjectable material can be introduced into the bone being treated. Thedelivery cannulae 12 is configured at the delivery cannulae distal end16 to have a securing edge 18 which serves to hold the delivery cannulae12 in place on the outer surface of the bone being treated. The deliverycannulae proximal end 20 is configured to have a handle retention member22, which serves to releasably secure a handle member 24 to the deliverycannulae 12. The handle member 24 can be used for insertion of thedelivery cannulae 12 over the aligning cannulae 6 and for improving thegrip of the user when placing the securing edge 18 of the deliverycannulae 12 firmly into position on the outer surface of the bone beingtreated. The removable handle member 24 also can be useful at a laterstep of the surgical procedure for providing a secure grip, which may benecessary to disengage the delivery cannulae 12 from the surface of thebone prior to extracting the device I from the body of the patient. Thesurface of the delivery cannulae can be provided with graduated indicia30 which provide depth of penetration information during insertion bythe user. The cannulae can be configured such that the cannulae isprimarily radiotranslucent with portions being radioopaque to provideindicia along a portion of the entire length of the cannulae. Theindicia can be equally disposed along the length of the cannulae, can bedisposed in a graduated increasing or decreasing scale, or can be acombined arrangement whereby some portion is of equal graduations andsome portion is of sliding increasing or decreasing graduations. It isalso within the concept of the present invention to provide aradioopaque cannulae having portions, which are radiotranslucent toprovide indicia. One aspect of the present invention is to include aradioopaque distal end of the cannulae to enable precise determinationof the location of the distal end during operation of the device. Theradioopaque indicia can be made radioopaque by any means known in theart to include the use of gold or other metals.

[0041] The guide wire 2 can be provided with graduated guide wireindicia 26 which extend from the tapered end 4 to the more proximalguide wire blunt end 28. The guide wire indicia 26 provides a means bywhich the user can easily determine the depth of insertion of the guidewire 2 into the patient during the surgical procedure of the presentinvention. The guide wire indicia can be arranged in an equaldistribution along the length of the guide wire or can be distributed inincreasing or decreasing graduation or a combination thereof.

[0042] A plunger member 32 can be provided with an ergonomicallyconfigured gripping member 34 at a first end which is used by the userto exert pressure on the plunger member 32 as it snuggly passes throughthe material conduit 14 of the delivery cannulae 12. The second end ofthe plunger member 32 is configured to have a blunt smooth tip 36. Thefit of the plunger member 32 within the material conduit 14 of thedelivery cannulae 12 is such that easy sliding engagement of the plungeris permitted without allowing the passage of the injectable materialproximally past the blunt smooth tip 36. Further, the plunger member 32is sized diametrically to provide a fit within the material conduit 14so as to permit the release of air proximally past the plunger whilemaintaining the PSI of the injected material as the plunger forces thematerial distally through the outer cannulae and into the subject. Theuser can, upon exerting force against the gripping member 34, displacethe plunger member 32 through the length of the material conduit 14 ofthe delivery cannulae 12 and, in doing so, displace any preloadedinjectable material out of the distal end of the material conduit 14,through the breach formed by the tapered end 4 of the guide wire 2 andinto the interior of the bone being treated.

[0043] Alternatively, the movement of the material through the materialconduit 14 and into the cancellous bone of the vertebrae could beaccomplished by means of a syringe system, generally shown in FIG. 4, at38. The syringe system of the present invention can include a fluidconnector 40, such as, for example, a conventional Luer lock, a bayonetfitting, a hydraulic quick disconnect fitting, or any other fluid tightfitting as is well known in the art. The fluid connector 40, which wouldbe attached to the delivery cannulae 12 and in fluid tight communicationwith the material conduit 14 can be attached directly to a syringe 42,to a syringe via a flexible conduit 44, or alternatively to an automatedinfusion device as is well know in the art (not shown). The syringesystem 42 can be provided with a syringe plunger tip 42 a, which caninclude one or multiple sealing rings diametrically sized to slidablymove within the syringe 42 in a manner conventional to syringes but withone or more air passages 42 b to allow the proximal flow of air past theplunger tip 42 a while the plunger tip 42 a forces the material distallythrough and out of the syringe 42 a. The air passages 42 b are sized topermit the flow of air but not the flow of the injectable material in aproximal direction within the syringe 42. Further, the air passages 42 bcan be arranged on one or more than one annular rings 42 c on theplunger tip 42 a. When multiple air passages 42 b are arranged onmultiple annular rings 42 c, it is preferred that the air passages 42 bthrough one annular ring 42 c are offset from the air passages 42 b froman adjacent annular ring 42 c. The fluid connector 40 can be attached tothe delivery cannulae 12 in approximate alignment to the longitudinalaxis of the delivery cannulae 12, at right angles to the longitudinalaxis of the delivery cannulae 12, or at any position or any angulararrangement to the delivery cannulae 12, which will permit fluid flowthrough the connector into the material conduit 14.

[0044] In the process of the present invention, the mixing of theinjectable material, such as bone cement, could be accomplished withinthe syringe system.

[0045] Another alternative mode of operation would permit the movementof the plunger can be automated by attachment of an electromechanical orpneumomechanical servo mechanism which would be under control of thephysician.

[0046] Without departing from the concept of the present inventionpresented in FIGS. 1-4, alternative embodiments of the intraosseousinjection device and peripheral elements as shown in FIGS. 5-12B can beprovided for use in the method of the present invention.

[0047] As best shown in FIG. 5, a locking guide wire 46, having anattached longitudinally aligned male Luer lock 48 and female Luer lock50 can be provided for use with a corresponding alternative deliverycannulae 52, the locking guide wire having corresponding guide wireconnectors 54. FIG. 7 shows the alternative delivery cannulae 52assembled with the locking guide wire 46. FIG. 8 shows a locking guidewire handle 56, which can be secured to the locking guide wire by theLuer lock 48.

[0048] As best shown in FIGS. 9A-9C, the locking guide wire handle 56defines a longitudinal lumen 58, which is sized and configured to permitpassage of the locking guide wire 46 as well as the larger crossdimension diameter of the delivery cannulae 52. The guide wire handle 56can be provided with a view slot 60, which may be equipped with amagnifying or non-magnifying clear cover (not shown). The viewing slot60 is sized and configured in the guide wire handle 56 to permit theuser to view the graduated guide wire indicia 26 during operation of thepresent invention. The ability to view the guide wire indicia 26 duringoperation of the present invention provides a safety feature, whichpermits the operator to know the depth of insertion of the subsequentlypositioned aligning cannulae and/or outer cannulae. The guide wirehandle 56 can define a first clearance hole 62, which provides crossaccess to the 10 longitudinal lumen 58 and has an orifice diameter sizedand configured to correspond to the guide wire 46 and can be used tohelp drive the aligning cannulae into position. The guide wire handle 56can be similarly configured to define a second clearance hole 66, whichserves much the same function as the first clearance hole with theexception that the second clearance hole is sized and configured toassist in the insertion of the large delivery cannulae 52. The impactconnector element 64 can be provided in cross-sectional diameters, whichcorrespond to either the first clearance hole 62 or the second clearancehole 66. The handle distal end 68 can be provided with a handle Luerconnector 70 which corresponds to connectors 54 of the alternativedelivery cannulae 52, thus providing a secure, quickly releasedconnection between the guide wire handle 56 and the alternative deliverycannulae 52. An enlarged cross-sectional view of the handle Luerconnector 70 is shown in FIG. 9B. Although the Luer type connectiondisclosed in detail is the preferred means of providing the handleconnection described above, it is within the concept of the presentinvention to provide the handle connection using any known connectionmeans, such as, for example, other threaded connections, snap-fitconnections, cotterpin connections, friction connections, and the like.

[0049] The locking guide wire 46 in combination with the attached guidewire handle 56 and the alternative delivery cannulae 52 provides a veryeffective modular pedicle finder which can be used to facilitate thelocation and penetration of the pedicle of a vertebra. The advantageoususe of the alternative delivery cannulae 52 in combination with such amodular pedicle finder provides the user with a device accessing thevertebral body by a transpedicular approach far superior to that knownin the art. The positioning and direction of insertion of the guide wire2, or locking guide wire 46 can be facilitated by using image guidancemeans such as fluoroscopy, CAT scan, MRI or the like. Stereotacticmethods and the employment of registration diodes can also be employedto provide accuracy in guide wire insertion when the process of theinvention is practiced from any approach to the vertebral body,including the use of the locking guide wire 46 to perform atranspedicular approach to the vertebral body. It is also within theconcept of the present invention to employ robotic systems to controlthe accuracy of the insertion of the device.

[0050] As best shown in FIG. 9D, one alternative embodiment of the guidewire handle 56 can be provided with a removable proximal end 72. Theremovable proximal end 72 permits the user to expose the proximal end ofthe guide wire for ease in movement, insertion, and extraction from thedelivery cannulae. The removable proximal end 72 of the guide wirehandle 56 can be releasably secured to the guide wire handle 56 by anyknown releasable connection means, such as, for example, threadedconnections, snap-fit connections, cotter-pin connections, frictionconnections, and the like. FIGS. 9E-9F show examples of some of thealternative end attachments which can be employed with the alternativeembodiment of the guide wire handle shown in FIG. 9D. Any configurationfor the removable proximal end 72 that provides a gripping surface forthe user is within the concept of the present invention. Preferredalternative embodiments of the removable proximal end 72 are thespherical or oval gripping surface 76 (FIG. 9E) and the T-handle form 78(FIG. 9F). Alternative handles which can be used with the presentinvention includes the cannulated T-handle shown in FIGS. 9G-9H. FIG. 9Iprovides a partial sectional view of one embodiment of the presentinvention utilizing another option for the removable proximal end 72,that of a removable impact extension member 72 a. This optional memberenables the user to attach an impact surface which surrounds andprotects the guide wire if impacting the device is necessary duringoperation.

[0051] FIG'S 10A-10C show details of an alternative plunger assembly 80which can have a removable gripping member 82, which is secured by aremovable lock pin 84 or similar securing member. The alternativeplunger assembly 80 with the gripping member 82 removed can beconfigured to an automated impelling means (not shown) much likeautomated infusion devices, which are known in the art. With thealternative plunger assembly 80 so configured, the degree of pressureapplied to the plunger assembly in moving the material through thematerial conduit can be automatically controlled by the user to avoidover pressurizing the material into the spaces within the bone. Theplunger assembly can be manufactured with a lock pin 84, which is notremovable. So configured, the plunger assembly would essentially be thatof the earlier described unitary plunger member 32.

[0052] FIGS. 10D-10J provide depictions of alternative embodiments ofthe present invention, which can use a standard threaded plunger andcannulae (FIGS. 10D-10E) or, as shown in FIGS. 10F-10G a long-threadedor optional mixing-tip plunger (FIG. 10K). Such embodiments of thepresent invention provide a controlled insertion of the plunger and aninherent resistance to any back pressure from the material beinginjected through the device. FIGS. 10H-10J depict alternative handleswhich can be used with any of the earlier described embodiments of thepresent invention; particularly those shown in FIGS. 10D-10G. The swivelball gripping member 82 a can be used to provide ease of movement of theplunger; particularly one of the threaded plungers depicted in FIGS.10D-10G.

[0053]FIG. 11A shows a hand operated plunger actuator 86, which can beused to assist in the impelling of the material through the materialconduit 14 of the present invention. FIG. 11B shows a type of syringe 42which can be used to contain the material for use in the method of thepresent invention, the syringe being an example of the type syringewhich can be used with the hand operated plunger actuator shown in FIG.11A. Other impelling devices can also be used to assist in the movementof the material into the material conduit 14 without departing from theconcept of the present invention.

[0054] The present invention also contemplates the use of anintraosseous injection device similar to the embodiments described abovewith the alternative modification of providing lumens which incorporaterifling along the bore of the lumen which can be of assistance to theuser in enabling the ease of material insertion and allowing the escapeof air or other fluids of less consistency than that of the materialbeing infused into the body. The tolerances between the plunger assembly32 or 80 and the sides of the material conduit 14 are such that thematerial is easily forced through the conduit without loss of thematerial around the plunger, yet air or other light consistency fluidswithin the material conduit 14 are allowed to pass away from the bodyaround the plunger to freely escape.

[0055] It is also within the concept of the present invention to providean intraosseous injection device which has multiple lumens for passageof the material into the body, thus allowing for the possibility ofmixing of material components at the time of injection. A multi-lumendevice 116 such as that shown in FIGS. 11C-11E can be used in a varietyof situations, to include, for example, when it is desirable to withholdmixing of injectable material components as long as possible prior toinjecting the mixed components into a subject. As best shown in FIG.11E, the device can be provided with a separate plunger 118 a, 118 b foreach lumen; the plungers being configured such that they can be operatedindependently or can be operated together by apply pressure to theoverriding handle of one of the plungers 118 a.

[0056]FIG. 12A shows an application of the method of the presentinvention, which employs a flexible delivery cannulae 88 for delivery ofa material into the bone material of a joint, such as, for example intothe acetabulum 90. A sealing washer 92 can be provided to assist inmaintaining the delivery cannulae 88 in place at the point of entry intothe bone. FIG. 12B is an enlarged cross-sectional depiction of theflexible cannulae shown in FIG. 12A showing an example of a mechanismwhich can be employed to steer the flexible delivery cannulae 88. FIG.12B depicts a steering wire system 94,, which employs at least twosteering wires 96, one end of each steering wire being attached at thedelivery cannulae distal end 98 in opposition one to the other and theother end of the respective steering wires being attached in oppositionone to the other to a rotary reel control 100 located adjacent to theLuer lock of the delivery cannulae. The steering wire system 94described herein and shown in FIG. 12B is provided as an example of asteering system which can be used in the present invention. It is,however, within the concept of the present invention to employ any ofthe known means of producing a steerable catheter.

[0057] Also provided is a specialized impact forceps 102, as shown inFIGS. 13A-13B. The specialized impact forceps can be used in conjunctionwith the device of the present invention for purpose of facilitating theentry of the device into the bone. The impact forceps 102, are operatedby a user much like surgical forceps known in the art. A hinge member104 connects the opposing halves 106 a and 106 b of the forceps allowingthe halves 106 a and 106 b to be closed tightly together. A forceps lock108 allows the halves 106 a and 106 b to be locked into a closedposition. Unique to the specialized forceps of the present invention isa first groove 110 and a second groove 112 found in the end of theforceps which is tightly closed when the forceps is in the closed andlocked position. The first groove 110 is sized and configured tosecurely grasp the guide wire element 2, which is sized to fit the firstclearance hole 62 of the guide wire handle. The second groove 112 issized and configured to securely grasp an impact connector element 64,which is sized to fit the second clearance hole 66 of the guide wirehandle. The forceps 102 can have a striking plate 114, which isconfigured to receive driving blows from an operator using a mallet,hammer, springloaded driver, or other impacting device. In combination,the forceps 102 and the first clearance hole 62 can be used tofacilitate driving the guide wire 46 into position in the bone.Similarly, the forceps 102 and the second clearance hole 66 can be usedto facilitate driving the delivery cannulae into position.

[0058] In its most general form, the surgical procedure of the presentinvention includes the step of the physician, by tactile sensation,recognizing the appropriate back-pressure on the plunger gripping memberand thereafter ceasing the manual introduction of injectable materialinto the cancellous bone. It is, however, within the scope of thepresent invention to provide a back-pressure sensor attached to thedevice 1 such that when the preselected back-pressure on the plungermember is reached, the physician is apprised of the situation andintroduction of material can be discontinued. It is further, within thescope of the present invention for the alternative embodiment whichprovides for automatic infusion of the biomaterial through the device 1,to provide a processor which receives a back-pressure signal at apreselected back-pressure and in turn transmits a pressure cut-offsignal to the automatic infusion system.

[0059] The injection device of the present invention can be fabricatedfrom any of a variety of materials, which are compatible for use assurgical instruments. Examples of such materials include metallicmaterials and non-metallic materials, which are suitable for use insurgical instrument manufacturing processes. Metallic materials caninclude, for example, surgical instrument grade stainless steel andalloys thereof, anodized aluminum and alloys thereof, and titanium andalloys thereof to include nickel-titanium. Non-metallic materials caninclude, for example, thermoplastics, ceramic materials, carbon fibermaterials, composite materials, and the like. Portions of the devicewhich are radioopaque can be constructed or coated with any radioopaquematerial, to include but not limited to gold or other metals.

[0060] It is within the scope of the present invention to provide a kit,which includes the injection device disclosed above. The kit could alsoinclude some or all of the alternative features discussed herein, toinclude the injectable material. Such a kit could be provided in anappropriate packaging, which could be designed for autoclaving or othermeans of sterilization.

[0061] In operation, the user can insert the guide wire 2 using aposterior lateral approach to the vertebral body. This can be safelydone with the patient under general or local anesthetic.

[0062] The surgical procedure of the present invention can be performedby direct vision, open or percutaneously, laproscopically,thorascopically, or by open surgical procedures. Performance of thesurgery percutaneously is preferred. A very important feature of thepresent invention is the ability to perform the surgical procedurepercutaneously by a posterior-lateral approach in addition to thetranspedicular approach. The use of a posterior-lateral approach ispreferred over the transpedicular approach because the physician canquickly, effectively and, most importantly, safely perform avertebroplasty without bringing any instruments within close proximityto the spinal cord. Alternatively, the method of the present inventioncan be performed using a transpedicular approach with the limited bonepenetration and accuracy of employment aspects of the present inventionproviding improved safety over conventional transpedicular approaches.

[0063] The surgical procedure is also easily adapted to be performed onany vertebrae from T3 down, which also represents a major expansion ofapplicability over the convention methods used.

[0064] Additionally, the procedure has been shown to be useful in fixingvertebral bodies which have tumors to the extent that the tumors havenot caused the formation of holes in the compact bone of the vertebraeadjacent to the spinal cord.

[0065] Of major importance is the very limited degree of penetration ofthe guide wire 2 through the compact bone of the vertebrae. Unlikeconventional vertebroplasty, which requires CAT scanning to preciselycontrol drilling using a conventional vertebroplasty apparatus throughthe pedicle (see FIG. 14 and FIG. 15), the present invention can be moreefficiently, and more quickly accomplished being aided only by the useof fluoroscopy. FIG. 14, shows the angle relative to the spinal columnfor transpedicular approaches using the conventional vertebroplastyapparatus and the conventional procedure of deeply penetrating into thecancellous bone of the vertebral body. The preferred posterior-lateralapproach to the vertebra by the guide wire 2 and the penetration of thetapered end, which need only penetrate the compact cortical bone of thevertebral body, results in the cancellous bone of the vertebra beingleft in tact. In the alternative transpedicular approach of the presentinvention the transpedicular approach angle is similar to conventionalmethods, however, the improved control of depth of penetration of theapparatus of the present invention provides greater accuracy andtherefore greater safety over conventional apparatus and methods. It iswell known in the art, as evidenced by the discussion in Gray's Anatomy,38th Ed. (1995) at page 427 and 454, that the relatively thin-walledexterior compact bone derives powerful support from the trabeculae ofcancellous bone located within. Conventional vertebroplasty drillsthrough and penetrates well into the cancellous bone of the vertebrae(see FIG. 15), thus severely disrupting the natural internal reinforcingstructure of the vertebra. In the preferred embodiment of the presentinvention the guide wire 2 does not penetrate through the cancellousbone and therefore does not radically disrupt the trabeculae of thecancellous bone.. The result is that when the bone cement is introducedthrough the material conduit 14 of the delivery cannulae 12, it flowsinto the naturally porous configuration of the intact cancellous bonethus taking advantage of, not replacing, the natural internal supportingtrabeculae structure of the vertebra.

[0066] As depicted in FIG. 16, In a first embodiment of the process ofthe present invention the vertebra are infused with bone cement using anentry port on one side only of the vertebra. This unilateral infusionprocess does not completely fill the porous structure of the naturalmatrix of the cancellous bone; but fills it sufficiently on one side tofully support the failed vertebra.

[0067] As depicted in FIG. 17, in an alternative embodiment of theprocess of the present invention the surgery can be done as a bilateralprocedure by first infusing the failed vertebra from one side and thenrepeating the entire process from the opposite side of the vertebra. Bysuch a bilateral approach, it is possible for the physician, if hedesires, to substantially fill all of the porous structure of thecancellous bone of the vertebra.

[0068] As depicted in FIG. 18, a further alternative embodiment of theprocess of the present invention could include the step of extending theguide wire 2 further into the cancellous bone of the vertebra and thuspositioning the material conduit 14 of the delivery cannulae 12 morecentral to the cancellous bone portion of the vertebrae. As the porousstructure of the cancellous bone is infused with bone cement using thisalternative process, the delivery cannulae 12 can be slowly withdrawnfrom the cancellous bone structure while continuing to infuse the bonewith bone cement. The result would be a substantially filled vertebraeusing a unilateral process.

[0069] As depicted in FIG. 19, an adjustable handle member, generallyshown as 120 in an exploded view, can be employed with the presentinvention. While the preferred embodiment of this adjustable handlemember 120 can have a T shaped grip 121 to improve the users grip -forturning the device, it is within the concept of the invention to have ahandle of any shape, which is suited for manual use. The handle shaft122, can be removably connected to the grip 121 by a grip connector 123.Located within a recess 124 of the handle shaft is an adjustment control125, which preferably can be in the form of a thumb wheel although otherequivalent embodiments are within the concept of the invention. Theadjustment control can have an adjustment connector 126, which can be inthe configuration of a pin. Within the handle shaft 122, a lumen 127 isprovided which can contain a torque connector assembly, generally shownat 127. The torque connector assembly 127 includes a tensioner 128,which is surrounded by a hollow torque sleeve 129. The torque sleeve 129is provided with an adjustment connector receiving slot 130, whichcooperates in a pin-slot manner with the adjustment connector 126. Thetorque sleeve 129 at its most distal end 131 is provided with a sleeveconnection member 132, the sleeve connection member 132 preferably beinga female luerlock, although other type connectors can also be used. Inoperation, as the adjustment control 125 is manually operated, it causesa corresponding movement in the adjustment connector 126. The adjustmentconnector 126 being in a pin-slot, or equivalent, operating arrangementwith the torque sleeve 129 causes a movement of the torque sleeve so asto effect an engagement of the sleeve connection member 132 at thedistal end 131 of the torque connector 129 to a complementary connector,preferably a male luerlock, on a cannulae or guide wire of the presentinvention. The tensioner 128, which is retained within the torqueconnector 129 serves to maintain tension on the assembly duringoperation.

[0070] As depicted in FIG. 20 a small stature luerlock guide wire 133can be provide for use in particularly small areas of operation. Whileused primarily for small areas of operation, the small stature luerlockguide wire 133 can be made in any size as needed. Further, the guidewire 133 is provided with a luerlock connector 133 a for ease ofconnection to any handle complementarily equipped. Other configurationsof connectors can also be employed within the concept of the invention.

[0071] As depicted in FIGS. 21A, 21B and 21C, a loading syringe,generally shown at 134 is provided with a loading syringe plunger andhandle assembly 135 and a loading syringe vessel 136. The loadingsyringe plunger and the loading syringe vessel 136 can be provided withgraduated indicia 137, 138 to assist the user in determining the volumeof material loaded in the syringe as well as the volume expelled duringoperation. The loading syringe 134 can also be provided with a flexibleloading syringe connector tube 138, which provides flexible connectionbetween the parts of the assembly. Connection between parts of theassembly are preferably by luerlock, although other connectors arewithin the scope of the invention. The proximal end 139 of the syringevessel 136 can be provided with a threaded connector 140, whichcooperates with a complimentary threaded connector 141 on the proximalend 142 of the flexible loading syringe connector tube 138. This entireassembly can be used as a means to facilitate loading of material intothe cannulae of the present invention.

[0072] As depicted in FIG. 22, hand operated syringe gun, generallyshown at 142 is provided, which can be used to facilitate the accurateexpulsion of material from the cannulae of the present invention. Thesyringe gun 142 is preferably hand operated, however, it is within theconcept of the invention to provide a mechanical or computer controlledassist to operate the syringe gun 142. In its preferred configuration ofmanual operation, the syringe gun 142 is provided with a gun grippingmember 143 and an operably connected gun actuator 144. Upon operation ofthe actuator 144, the driving member 145, which is preferably formed ina rod-like configuration, is moved in carefully graduated amounts so asto force the integrally assembled plunger member 146 into a removablyconnected gun syringe tube 147. Flow control members can be disposedalong the length of the driving member 145. The flow control members canoperationally interact with the actuator 144 to limit flow of materialout of the syringe gun 142 to as little as 1 cc of material peractuation by an operator. The syringe tube 147 can be removably mountedonto the syringe gun by a standard luerlock type connection or any otherconnection known in the art. In operation, as the plunger member 146moves through the lumen of the syringe tube 147, the air containedwithin the lumen is vented through air vents 148, which can be formed inat least one of the concentrically arranged plunger ribs 149 which forma sliding connection between the interior wall of the syringe tube 147and the plunger member 146. The air vents 148 are preferably multipleand not aligned with air vents 148 for sequentially placed plunger ribs149. This arrangement permits air within the syringe tube 147 to escapeduring operation without the loss of the fluid contents of the syringetube.

[0073] It should be known that while the surgical process of the presentinvention described above is particularly appropriate to providefixation of vertebral compression failures due to osteoporosis, tumor orother pathogenic bone conditions, the process can also be used in casesof trauma induced compression failures. Further, it is possible that theprocess could be used as a preventive or protective measure that couldconceivably be used for patients, which present themselves as beingextremely likely to suffer vertebral compression failures.

What we claim is:
 1. An injection device comprising: a delivery cannulaehaving a proximal end and a distal end, which are connected by acannulae body, with a proximal end and a distal end, said cannulae bodyhaving indicia disposed along at least a portion of said cannulae bodybetween said distal end and said proximal end and having a lumen capableof acting as a material conduit, said lumen passing from said proximalend through said distal end; an elongated plunger, said plunger beingsized and configured to slidably pass through said lumen; a removablehandle configured for secure attachment to said proximal end of saiddelivery cannulae, said delivery cannulae being equipped with a handleretention member integrally formed in said proximal end of said deliverycannulae.
 2. An injection device according to claim 1, furthercomprising: an elongated guide wire, said guide wire having a first endand a second end connected by an elongated guide wire body, said firstend being configured with a taper, said taper being capable of breachingcortical bone sufficient to form a channel through said cortical bone;and an aligning cannulae having a gripping end and a tapered end, saidaligning cannulae being sized and configured to slidably passcircumferentially over said guide wire and said delivery cannulae beingsized and configured to slidably pass circumferentially over saidaligning cannulae.
 3. An injection device according to claim 2, whereinsaid guide wire comprises graduated guide wire indicia disposed alongsaid guide wire body between said first end and said second end of saidguide wire body.
 4. An injection device according to claim 2, whereinsaid graduated indicia on said delivery cannulae are radioopaque andsaid cannulae is radiotranslucent.
 5. An injection device according toclaim 2, wherein said cannulae is radioopaque and said graduated indiciaare radiotranslucent.
 6. An injection device according to claim 3,wherein said guide wire comprises indicia disposed along at least aportion of the length of said guide wire.
 7. An injection deviceaccording to claim 6, wherein said guide wire indicia areradiotranslucent and said guide wire is radioopaque.
 8. An injectiondevice according to claim 2, wherein said guide wire further comprises aremovable handle..
 9. An injection device according to claim 8, whereinsaid removable handle comprises a removable proximal end.
 10. Aninjection device according to claim 2, wherein said plunger comprises amixing tip.
 11. An injection device comprising: a delivery cannulaehaving a proximal end and a distal end, which are connected by acannulae body, with a proximal end and a distal end, said cannulae bodyhaving said lumen having graduate indicia disposed along at least aportion of said cannulae body between said distal end and said proximalend and a lumen capable of acting as a material conduit, said lumenpassing from said proximal end through said distal end; a syringe systemreleasably connected to said delivery cannulae and in fluidcommunication with said cannulae lumen; a removable handle configuredfor secure attachment to said proximal end of said delivery cannulae,said delivery cannulae being equipped with a handle retention memberintegrally formed in said proximal end of said delivery cannulae.
 12. Aninjection device according to claim 11, wherein said syringe system isremovably connected to said delivery cannulae by a connector selectedfrom the group consisting of a Luer lock, a bayonet fitting, and ahydraulic quick disconnect fitting.
 13. An injection device according toclaim 12, wherein said connector is integral with said proximal end ofsaid delivery cannulae and is aligned with the longitudinal axis of saiddelivery cannulae body.
 14. An injection device according to claim 11,wherein said syringe system is connected to said delivery cannulae by aflexible conduit.
 15. An injection device according to claim 2, whereinsaid guide wire comprises an attached longitudinally aligned a Luer lockconnector.
 16. An injection device according to claim 15, wherein saidhandle comprises a Luer lock configured to releasably engage said Luerlock connector of said guide wire, said handle further comprising alongitudinally aligned lumen opening at each end of said handle.
 17. Aninjection device according to claim 12, wherein said connector of saiddelivery cannulae is a Luer lock and said handle comprises a Luer lockconfigured to releasably engage said Luer lock connector of saiddelivery cannulae, said handle further comprising a longitudinallyaligned handle lumen opening at each end of said handle, said handlelumen being in fluid communication with said lumen of said deliverycannulae.
 18. An injection device according to claim 17, wherein saidhandle further comprises a view slot sized and configured to permitviewing of the handle lumen.
 19. An injection device according to claim17, wherein said handle further comprises a first clearance hole passingthrough said handle perpendicular to said handle lumen, said firstclearance hole being sized and configured to slidably receive said guidewire.
 20. An injection device according to claim 19, wherein said handlefurther comprises a second clearance hole passing through said handleperpendicular to said handle lumen, said second clearance hole beingsized and configured to slidably receive said aligning cannulae.
 21. Aninjection device according to claim 17, wherein said handle furthercomprises a removable proximal Luer lock end.
 22. An injection deviceaccording to claim 11, wherein said syringe system comprises anautomated impelling unit.
 23. An injection device according to claim 22,wherein said automated impelling unit being capable of controlling therate and amount of movement of the mechanism of said syringe system. 24.An injection device according to claim 23, wherein said automatedimpelling unit further comprises a pressure sensing unit.
 25. Aninjection device according to claim 2, wherein said device is formed ofmaterials selected from the group consisting of stainless steel,anodized aluminum, thermoplastics and glass.
 26. An injection deviceaccording to claim 2, wherein said delivery cannulae lumen comprisesmultiple lumens.
 27. An injection device according to claim 1, furthercomprising: an elongated guide wire, said guide wire having a first endand a second end connected by a elongated guide wire body, and saidfirst end being configured with a taper, said taper being capable ofbreaching cortical bone sufficient to form a channel through saidcortical bone, wherein said delivery cannulae is sized and configured toslidably pass circumferentially over said guide wire.
 28. An injectiondevice according to claim 27, wherein said injectable material isselected from the group consisting of bone cement, antibiotics, cellularimplants, natural products of cells recombinant nucleic acid products,protein products of recombinant cells.
 29. A surgical device for findingthe pedicle portion of a vertebra of a subject comprising: a guide wire,said guide wire having a connection member; a guide wire handleconfigured for connection to said guide wire connection member; and acannulae sized and configured to pass over said guide wire.
 30. A kitfor introducing an injectable material into a subject, the kitcomprising: an injection device according to claim 1; and an injectablematerial selected from the group consisting of bone cement, antibiotics,whole cellular implants, natural products of cells, recombinant nucleicproducts and protein products of recombinant cells.
 31. A kit accordingto claim 30, wherein said injectable material is polymethylmethacrylate.32. A kit for introducing an injectable material into a subject, the kitcomprising: an injection device according to claim 11; and an injectablematerial selected from the group consisting of bone cement, antibiotics,whole cellular implants, natural products of cells, recombinant nucleicproducts and protein products of recombinant cells.